A New Practical Decision Rule to Better Differentiate BI-RADS© 3 or 4 Breast Masses on Breast Ultrasound.
BI-RADS; breast mass; decision rule; malignancy; reliability; ultrasound; BI-RADS; breast mass; decision rule; malignancy; reliability; ultrasound
Objectives: The BI-RADS© classification provides a standardized way to describe ultrasound findings in breast cancer diagnostics. However, there is little information regarding which BI-RADS© descriptors are most strongly associated with malignancy, to better distinguish BI-RADS© 3 (follow-up imaging) and 4 (diagnostic biopsy) breast masses.; Methods: Patients were recruited as part of an international, multicenter trial (NCT02638935). The trial enrolled 1294 women (6 excluded) categorized as BI-RADS© 3 or 4 upon routine B-mode ultrasound examination. Ultrasound images were evaluated by three expert physicians according to BI-RADS©. All patients underwent histopathological confirmation (reference standard). We performed univariate and multivariate analyses (chi-square test, logistic regression, and Krippendorff's alpha).; Results: Histopathologic evaluation showed malignancy in 368 of 1288 masses (28.6%). Upon performing multivariate analysis, the following descriptors were significantly associated with malignancy (P < .05): age ≥50 years (OR 8.99), non-circumscribed indistinct (OR 4.05) and microlobulated margin (OR 2.95), nonparallel orientation (OR 2.69), and calcification (OR 2.64). A clinical decision rule informed by these results demonstrated a 97% sensitivity and missed fewer cancers compared to three physician experts (range of sensitivity 79-95%) and a previous decision rule (sensitivity 59%). Specificity was 44% versus 22-83%, respectively. The inter-reader reliability of the BI-RADS© descriptors and of the final BI-RADS© score was fair-moderate.; Conclusions: A patient should undergo a diagnostic biopsy (BI-RADS© 4) instead of follow-up imaging (BI-RADS© 3) if the patient is 50 years or older or exhibits at least one of the following features: calcification, nonparallel orientation of mass, non-circumscribed margin, or posterior shadowing. (© 2021 The Authors. Journal of Ultrasound in Medicine published by Wiley Periodicals LLC on behalf of American Institute of Ultrasound in Medicine.)
Pfob A; Barr RG; Duda V; Büsch C; Bruckner T; Spratte J; Nees J; Togawa R; Ho C; Fastner S; Riedel F; Schaefgen B; Hennigs A; Sohn C; Heil J; Golatta M
Journal Of Ultrasound In Medicine
2021
2021-05-04
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journalArticle
<a href="http://doi.org/10.1002/jum.15722" target="_blank" rel="noreferrer noopener">10.1002/jum.15722</a>
A New Practical Decision Rule to Better Differentiate BI-RADS© 3 or 4 Breast Masses on Breast Ultrasound.
The BI-RADS classification provides a standardized way to describe ultrasound findings in breast cancer diagnostics. However, there is little information regarding which BI-RADS descriptors are most strongly associated with malignancy, to better distinguish BI-RADS 3 (follow-up imaging) and 4 (diagnostic biopsy) breast masses.
Patients were recruited as part of an international, multicenter trial (NCT02638935). The trial enrolled 1294 women (6 excluded) categorized as BI-RADS 3 or 4 upon routine B-mode ultrasound examination. Ultrasound images were evaluated by three expert physicians according to BI-RADS. All patients underwent histopathological confirmation (reference standard). We performed univariate and multivariate analyses (chi-square test, logistic regression, and Krippendorff's alpha).
Pfob A; Barr RG; Duda V; Büsch C; Bruckner T; Spratte J; Nees J; Togawa R; Ho C; Fastner S; Riedel F; Schaefgen B; Hennigs A; Sohn C; Heil J; Golatta M
Journal Of Ultrasound In Medicine
2021
2021-05-04
Journal Article
<a class="epub-doi" href="https://doi.org/10.1002/jum.15722">10.1002/jum.15722</a>
A New Practical Decision Rule to Better Differentiate BI-RADS 3 or 4 Breast Masses on Breast Ultrasound
Objectives: The BI-RADS classification provides a standardized way to describe ultrasound findings in breast cancer diagnostics. However, there is little information regarding which BI-RADS descriptors are most strongly associated with malignancy, to better distinguish BI-RADS 3 (follow-up imaging) and 4 (diagnostic biopsy) breast masses.
Methods: Patients were recruited as part of an international, multicenter trial (NCT02638935). The trial enrolled 1294 women (6 excluded) categorized as BI-RADS 3 or 4 upon routine B-mode ultrasound examination. Ultrasound images were evaluated by three expert physicians according to BI-RADS. All patients underwent histopathological confirmation (reference standard). We performed univariate and multivariate analyses (chi-square test, logistic regression, and Krippendorff's alpha).
Results: Histopathologic evaluation showed malignancy in 368 of 1288 masses (28.6%). Upon performing multivariate analysis, the following descriptors were significantly associated with malignancy (P < .05): age ≥50 years (OR 8.99), non-circumscribed indistinct (OR 4.05) and microlobulated margin (OR 2.95), nonparallel orientation (OR 2.69), and calcification (OR 2.64). A clinical decision rule informed by these results demonstrated a 97% sensitivity and missed fewer cancers compared to three physician experts (range of sensitivity 79-95%) and a previous decision rule (sensitivity 59%). Specificity was 44% versus 22-83%, respectively. The inter-reader reliability of the BI-RADS descriptors and of the final BI-RADS score was fair-moderate.
Conclusions: A patient should undergo a diagnostic biopsy (BI-RADS 4) instead of follow-up imaging (BI-RADS 3) if the patient is 50 years or older or exhibits at least one of the following features: calcification, nonparallel orientation of mass, non-circumscribed margin, or posterior shadowing.
André Pfob
Richard G Barr
Volker Duda
Christopher Büsch
Thomas Bruckner
Julia Spratte
Juliane Nees
Riku Togawa
Chi Ho
Sarah Fastner
Fabian Riedel
Benedikt Schaefgen
André Hennigs
Christof Sohn
Joerg Heil
Michael Golatta
J Ultrasound Med
. 2022 Feb;41(2):427-436. doi: 10.1002/jum.15722. Epub 2021 May 4.
2022
English
The potential of combined shear wave and strain elastography to reduce unnecessary biopsies in breast cancer diagnostics - An international, multicentre trial
Background: Shear wave elastography (SWE) and strain elastography (SE) have shown promising potential in breast cancer diagnostics by evaluating the stiffness of a lesion. Combining these two techniques could further improve the diagnostic performance. We aimed to exploratorily define the cut-offs at which adding combined SWE and SE to B-mode breast ultrasound could help reclassify Breast Imaging Reporting and Data System (BI-RADS) 3-4 lesions to reduce the number of unnecessary breast biopsies.
Methods: We report the secondary results of a prospective, multicentre, international trial (NCT02638935). The trial enrolled 1288 women with BI-RADS 3 to 4c breast masses on conventional B-mode breast ultrasound. All patients underwent SWE and SE (index test) and histopathologic evaluation (reference standard). Reduction of unnecessary biopsies (biopsies in benign lesions) and missed malignancies after recategorising with SWE and SE were the outcome measures.
Results: On performing histopathologic evaluation, 368 of 1288 breast masses were malignant. Following the routine B-mode breast ultrasound assessment, 53.80% (495 of 920 patients) underwent an unnecessary biopsy. After recategorising BI-RADS 4a lesions (SWE cut-off ≥3.70 m/s, SE cut-off ≥1.0), 34.78% (320 of 920 patients) underwent an unnecessary biopsy corresponding to a 35.35% (320 versus 495) reduction of unnecessary biopsies. Malignancies in the new BI-RADS 3 cohort were missed in 1.96% (12 of 612 patients).
Conclusion: Adding combined SWE and SE to routine B-mode breast ultrasound to recategorise BI-RADS 4a patients could help reduce the number of unnecessary biopsies in breast diagnostics by about 35% while keeping the rate of undetected malignancies below the 2% ACR BI-RADS 3 definition.
Michael Golatta
André Pfob
Christopher Büsch
Thomas Bruckner
Zaher Alwafai
Corinne Balleyguier
Dirk-André Clevert
Volker Duda
Manuela Goncalo
Ines Gruber
Markus Hahn
Panagiotis Kapetas
Ralf Ohlinger
Matthieu Rutten
Riku Togawa
Mitsuhiro Tozaki
Sebastian Wojcinski
Geraldine Rauch
Joerg Heil
Richard G Barr
Eur J Cancer
. 2022 Jan;161:1-9. doi: 10.1016/j.ejca.2021.11.005. Epub 2021 Dec 5.
2022
English